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510(k) Data Aggregation

    K Number
    K210199
    Device Name
    RICOH MEG
    Manufacturer
    Ricoh Company, Ltd.
    Date Cleared
    2021-07-02

    (158 days)

    Product Code
    OLX, OLY
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ricoh Company, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory activity in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epilentic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
    Device Description
    The RICOH MEG Analysis is an analysis software package used for processing and analyzing MEG data. It displays digitized MEG signals, EEG signals, topographic maps, and registered MRI images. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic MEGvision Software of Eagle Technology, Inc. (K040051). The RICOH MEG Analysis is designed to aid clinicians in the assessment of patient anatomy, physiology, electrophysiology and pathology and to visualize source localization of MEG signals.
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